Role of Human Errors in CAPAs

What is a “HUMAN ERROR”? Is it a Human error? Can we prevent these error occurrences? What could be the possible cause or situation which leads to these “Human error”?

FDA is very serious about Root cause analysis and effective CAPA management, but when most of the RCA comes to a conclusion as “Human error”; it is not accepted by FDA. We must analyse all the possible situation and factors which leads towards these kinds of errors.

We all know that Genuine human errors do happen, but if they’re cited far more frequently than they should be; it is a matter of concern. In the real scenario, most problems that appear to be caused by human error—especially those that occur multiple times; are rooted in processes or systems that are left unchanged. These errors will keep producing the problem despite the convenient corrective actions often placed over them. When human error is identified more frequently, it signals to investigators that problems aren’t being investigated thoroughly enough, thereby shifting them into problem-hunting mode and that it's high time to assess and modify quality management system up to even greater scrutiny.

Now Let’s talk about the rare instances where one-time errors are made by otherwise well-trained personnel following well-defined processes? A moment of a passing distraction can lead to serious problems. In these cases, the human error classification may be justified after a thorough investigation. It should only be considered as a viable justification when every other possible cause has been exhaustively explored and eliminated. Human errors need to be investigated in order to determine whether actions (or inactions) were deliberate or inadvertent. The outcome can help you determine whether human behaviour really is to blame as well as where you might expect to find a problem elsewhere (such as inadequate training, poor SOPs, lack of system controls etc.). Enter the Skills, Rules Knowledge/Generic Error Modelling System illustrated below.

It’s relatively simple but offers a reliable way to find out genuine human errors from other problems.

Following this model, errors that are shown to be “inadvertent” can be considered genuinely “human”, which then fall into one of three categories: skill-based/, rule based, or knowledge-based mistakes.

Those that are skill-based can be broken down further, into either a slip or a lapse. Both these point to the same root cause: a lack of attention, which manifests itself in two different ways: momentary memory loss or a routine action that wasn’t performed.

Once more, it’s important to note that these types of errors should not be happening frequently. The majority of problems that appear to be human error at first should lead you elsewhere upon further analysis.

Errors shown to fall into one of the two other categories should be viewed through a different lens. In these situations, processes—particularly related to training and oversight should be scrutinized as contributors as explained in the breakdown below:

1. Knowledge-based Errors: hese types of errors occur when someone was multitasking beyond their limit or were otherwise unable to devote the focus required to accomplish multiple tasks at once. In this situation, identify why the person was multitasking in the first place. The root cause likely lies here.

• Were they tasked with doing too many things at once?
• Is that department under-resourced?
• Was this individual’s supervisor aware that the person is multitasking beyond their limit?

1. Rule-based Errors: These errors are more technical in nature, such as someone applying an incorrect rounding rule which ultimately generates an out-of-specification (OOS) result. In this situation, rather than faulting an individual’s judgement, which may not be at fault, question why the person wasn’t adequately prepared to perform the task correctly.

• Did they receive insufficient practice in training?
• Did practice reflect the operations they were performing on the floor?
• Does the procedure specify the details to the degree they need to be explained in order to be performed correctly

Two Places to Look for Systemic “Human” Errors

When errors are revealed to be less “human” upon closer examination, start asking questions that cast light on how the type of work in question is actually being done. This may lead you to discover the problem may be more serious and widespread, particularly in one of two areas summarized below.

• Documentation
• FDA-regulated manufacturing operations are followed by documentation every step of the way. If human error is found, take a hard look at your written records and ask the questions listed below. The real problems may lie in your processes for creating, maintaining, and distributing the documentation that drives your quality system.
• Are change processes long and cumbersome?
• Are your staff working with out-of-date or obsolete SOPs?
• Are your SOPs readily accessible? Can employees easily navigate to them and understand the information they need?
• Do your SOPs and other documentation align in terminology and structure?
• Do staff use and trust documentation or is it common practice to seek answers from other sources?
• Do procedures given during training match those your staff follow on the job?

Culture

One of the best ways to immediately enhance quality throughout your organization is to realize most of the problems being described as human errors are something else entirely. Rather than using it as a convenient stand in for thorough investigation, use human error as an opportunity to improve your company’s problem-solving processes. Fast closure rates of inaccurate deviations don’t demonstrate efficiency, just misguided values on the problem-solving process itself.

Replace this metric with a trending reduction in total deviations over time. The size of your backlog and closure times are functions of each other and should be handled accordingly. Keep in mind that the lack of a backlog will likely lead investigators to look at your closure trends. If your deviation backlog is reduced significantly in the weeks leading up to their arrival, they’ll know your methods were rushed rather than being a natural component of your QMS.

Important Action Items:

• Conduct an objective assessment of your internal problem-solving processes (ideally with the help of an experienced third party) and remediate accordingly.
• Replace metrics that establish problematic incentives with goals focused on long-term trending.
• Explore ways to improve problem-solving within your QMS to reduce backlogs while thoroughly investigating issues.